Attention, parents: There's a very important recall you need to know about before giving your kids any pain relief medications.

What, exactly, is being recalled?

On March 2, the Food and Drug Administration (FDA) announced a recall for Strides Pharma's 100-milligram Children's Ibuprofen Oral Suspension. It updated the notice on March 16, giving the recall a Class II designation.

The product, the recall explained, was sold in a 4-fluid-ounce bottle. The recalled bottles have the specific lot numbers 7261973A and 7261974A printed on the label, as well as the expiration date January 31, 2027. The product was also shipped to locations across the U.S.

Why is children’s ibuprofen being recalled?

According to the notice, the product is being recalled due to the presence of a foreign substance. Specifically, it noted that "the firm received complaints for a gel-like mass and black particles in the product." It did not explain what that mass or particles could be.

Why did the FDA designate it as Class II?

The FDA categorizes its recalls with three classifications, with Class I being the most severe and Class III being the least severe. The FDA's definitions are as follows:

  • Class I recall: a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death
  • Class II recall: a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
  • Class III recall: a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences

This means the FDA determined that this specific Ibuprofen recall was severe enough that it could cause temporary adverse health effects.

What should I do if I have this product in my medicine cabinet?

While the FDA did not give specific guidance in its recall notice, it is always advised not to use a recalled item and to either discard it or return it to your place of purchase instead.